Drug product
CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
D-1633-2019
Product summary
- Firm
- Unipharma, Llc.
- Event
- Event 83492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 cartons
- Official record key
drug-enforcement:D-1633-2019
Official wording
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Code information: Lot: 90008 Exp. 02/28/21
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations